An observational study in Strep Throat, sponsored by Guangzhou Wondfo Biotech Co., Ltd. Suspended at 2 sites in United States. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Guangzhou Wondfo Biotech Co., Ltd · Observational
This study is designed to determine the accuracy of the Preview Rapid Strep A Test compared to a laboratory reference method for Group A Streptococcal infection and to determine the precision of the Preview Rapid Strep A test.
155 studies on the registry are indexed under Streptococcal Infections; 15 are open to participants now.
This study's planned enrollment of 320 is close to the median of 339 across 42 observational studies indexed under Streptococcal Infections.
Browse Streptococcal Infections studies →Guangzhou Wondfo Biotech Co., Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 320 patients to be tested, expecting 50-100 positive for Strep A collected from patients of any age and gender from two CLIA waived or waivable sites. Children will be enrolled in this study due to the high prevalence of Strep A infections in minors and the intention to market this investigational device for use for all ages following FDA clearance.
Any patient presenting with symptoms of pharyngitis
Exclusion Criteria:
Any patient presenting with symptoms of pharyngitis * Fever * Sore throat * Swollen lymph nodes in neck * Redness of throat/tonsils * White/yellow patches on tonsils * Not currently on antibiotics
Diagnostic Test: Preview Rapid Strep A test
Rapid assay for the detection of type A streptococcal infection of the throat.
Accuracy of Preview Strep A Rapid Test
Determination of Positive Predictive Value and Negative Predictive Value for Preview Strep A
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Guangzhou Wondfo Biotech Co., Ltd